cGMP Facility at 855 California Avenue

  • Project area: 12,500 sf
  • Schedule: Estimated start Spring 2015 – Estimated completion Fall 2015
  • Architect: DGA
  • General Contractor: Dome Construction – preconstruction services
  • SoM Project Manager: Laura Blackwood

Scope of Work

Stanford Medicine is preparing an FDA regulation Current Good Manufacturing Practice (cGMP) Cell Therapy Facility at 855 California Ave. The leased space is approximately 25,000 SF with 12,500 SF of tenant improvements planned for the cGMP manufacturing lab. Stanford Medicine will design and construct the lab space to produce individualized therapies for phases one and two clinical trials. These cell therapies include TR1 Cell Manipulations, Hematopoietic Stem Cells, Epithelial Tissue Graft Production and Vector production. The renovation work includes new wet lab, procedure rooms, irradiator, cell sorter, cGMP quarantine, quality control lab, new staff work areas, office, shipping and receiving, and cGMP materials storage / freezer areas. The lab and processes within must comply with FDA regulations for a Current Good Manufacturing Practice facility, cGMP guidelines which require the facility to maintain a high level of sterility, a strict protocol for chain of custody, and safeguards to ensure consistent performance.